Method and apparatus of smartly controlled endotracheal tube

Abstract

A method and apparatus for a smartly controlled dual-cuff endotracheal tube. A fully automatic or manual closed-negative-feedback loop control logic inflates/deflates a dual-cuff mechanism inside a patient's trachea. Separate inflating and deflating units with independent air control functions control the pressure based on signals from the cuff pressure control system. The dual-cuff mechanism comprises an inner and outer cuff connected to pilot balloons with individual pressure sensors to measure pressure and send data to the control system to calculate the delta. The inner cuff has an opening that serves as a pressure equilibrium indicator for the optimal cuff pressure being achieved. The apparatus can be manufactured to be a disposable product after a single use. The disclosure achieves: increased control and ease of use; increased accuracy, range, and control of pressurized airflow; an improved way of determining ideal cuff pressures in real-time; improved hygiene; and decreased costs.

1 . An endotracheal intubation apparatus for intubating a patient, comprising:
 an endotracheal tube having a proximal end, a distal end, and a circumference, the distal end insertable into the patient's trachea for intubating;   an expandable cuff attached around the circumference of the endotracheal tube towards the distal end;   a pressure pipe, a pilot balloon, a balloon sensor, and an inflation and deflation unit; wherein the pilot balloon, balloon sensor, inflation and deflation units are disposed towards the distal end of the endotracheal tube, the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon, the balloon sensor measures the pneumatic pressure of the cuff, the deflation and inflation units are adaptable for respectively deflating and inflating the cuff;   a cuff control system disposed towards the distal end and is electrically connected to the balloon sensor, the power source, deflation unit, and inflation unit; wherein the cuff control system controls the deflation unit and inflation unit to achieve a predetermined pressure in the cuff for sealing space between the patient's trachea and the circumference of the endotracheal tube with the inflated cuff based on the cuff air pressure sensed by the balloon sensor according to a negative feedback control loop scheme.   
     
     
         2 . The apparatus of  claim 1 , further comprising a power source disposed towards the distal end for energizing the endotracheal intubation apparatus. 
     
     
         3 . The apparatus of  claim 1 , wherein the pressure pipe travels along the endotracheal tube; wherein the negative feedback control loop scheme for the cuff control system to maintain the cuff pressure within a predetermined range comprises: activating the deflation unit if the pressure in the cuff increases above the predetermined range and activating the inflation unit if the pressure in the cuff falls below the predetermined range. 
     
     
         4 . The apparatus of  claim 1 , wherein the cuff comprises an inner cuff with an inner cuff opening and an outer cuff encapsulating the inner cuff; wherein the pressure pipe comprises an outer pressure pipe and an inner pressure pipe; wherein the pilot balloon comprises an outer pilot balloon and an inner pilot balloon; wherein the balloon sensor comprises an outer balloon sensor and an inner balloon sensor for measuring the pneumatic pressure of the outer cuff and the inner cuff, respectively; wherein the inner pressure pipe pneumatically connects the inner cuff both to the deflation unit and the inflation unit via the inner pilot balloon, and wherein the outer pressure pipe and the inner pressure pipe pneumatically connect the outer cuff and the inner cuff to the outer pilot balloon and the inner pilot balloon, respectively. 
     
     
         5 . The apparatus of  claim 4 , wherein the pressures of the inner and outer cuff are optimal and determined from the following steps: the inner cuff getting higher inflating pressure due to directly receiving pressurized air from the inflation unit via the inner pressure pipe leading to eventual contact with the inner surface of the outer cuff until it getting sealed and the cuff pressure in both cuffs reaching equilibrium (P1=P2 or DP=0); the inner cuff being inflated more and pushing the outer cuff further to seal the trachea; stopping the inflation at the measured pressure level reaching a threshold. 
     
     
         6 . The apparatus of  claim 1 , wherein the cuff control system monitors the balloon sensor at predetermined intervals to maintain the predetermined pressure in the cuff. 
     
     
         7 . The apparatus of  claim 1 , wherein the shape of the cuff is a donut, triangular, square, or oval. 
     
     
         8 . The apparatus of  claim 1 , wherein the cuff control system activates the deflation unit and/or the inflation unit in discreet steps or in a continuous manner to achieve/maintain the predetermined pressure. 
     
     
         9 . The apparatus of  claim 1 , wherein the deflation unit and the inflation unit are operable and mutually independent of each other. 
     
     
         10 . The apparatus of  claim 1 , wherein the cuff control system simultaneously activates the deflation unit and the inflation unit to maintain the predetermined pressure. 
     
     
         11 . The apparatus of  claim 1 , wherein the cuff control system is operable as a fully automatic smart control system. 
     
     
         12 . The apparatus of  claim 1 , wherein the balloon sensor is adaptable to measure air volume, airflow, and/or temperature. 
     
     
         13 . The apparatus of  claim 4 , wherein the inner cuff opening comprises a plurality of openings. 
     
     
         14 . The apparatus of  claim 4 , wherein the inner cuff opening is circular, oval, square, and triangle in shape. 
     
     
         15 . A method for intubating a patient with an endotracheal tube, comprising:
 providing an endotracheal tube having a proximal end, a distal end, and a circumference, the distal end insertable into the patient's trachea for intubating;   providing an expandable cuff attached around the circumference of the endotracheal tube towards the distal end;   providing a pressure pipe, a pilot balloon, a balloon sensor, and an inflation and deflation unit; wherein the pilot balloon, balloon sensor, inflation and deflation units are disposed towards the distal end of the endotracheal tube, the pressure pipe pneumatically connects the cuff to the deflation unit and inflation unit via the pilot balloon, the balloon sensor measures the pneumatic pressure of the cuff, the deflation and inflation units are adaptable for respectively deflating and inflating the cuff;   providing a cuff control system disposed towards the distal end and is electrically connected to the balloon sensor, the power source, deflation unit, and inflation unit; wherein the cuff control system controls the deflation unit and inflation unit to achieve a predetermined pressure in the cuff for sealing space between the patient's trachea and the circumference of the endotracheal tube with the inflated cuff based on the cuff air pressure sensed by the balloon sensor according to a negative feedback control loop scheme.   
     
     
         16 . The method of  claim 15 , further comprising providing a power source disposed towards the distal end for energizing the endotracheal intubation apparatus; wherein the pressure pipe travels along the endotracheal tube; wherein the negative feedback control loop scheme for the cuff control system to maintain the cuff pressure within a predetermined range comprises: activating the deflation unit if the pressure in the cuff increases above the predetermined range and activating the inflation unit if the pressure in the cuff falls below the predetermined range. 
     
     
         17 . The method of  claim 15 , wherein the cuff comprises an inner cuff with an inner cuff opening and an outer cuff encapsulating the inner cuff; wherein the pressure pipe comprises an outer pressure pipe and an inner pressure pipe; wherein the pilot balloon comprises an outer pilot balloon and an inner pilot balloon; wherein the balloon sensor comprises an outer balloon sensor and an inner balloon sensor for measuring the pneumatic pressure of the outer cuff and the inner cuff, respectively; wherein the inner pressure pipe pneumatically connects the inner cuff both to the deflation unit and the inflation unit via the inner pilot balloon, and wherein the outer pressure pipe and the inner pressure pipe pneumatically connect the outer cuff and the inner cuff to the outer pilot balloon and the inner pilot balloon, respectively; wherein the pressures of the inner and outer cuff are optimal and determined from the following steps: the inner cuff getting higher inflating pressure due to directly receiving pressurized air from the inflation unit via the inner pressure pipe leading to eventual contact with the inner surface of the outer cuff until it getting sealed and the cuff pressure in both cuffs reaching equilibrium (P1=P2 or DP=0); the inner cuff being inflated more and pushing the outer cuff further to seal the trachea; stopping the inflation at the measured pressure level reaching a threshold. 
     
     
         18 . The method of  claim 15 , wherein the cuff control system monitors the balloon sensor at predetermined intervals to maintain the predetermined pressure in the cuff; wherein the shape of the cuff is a donut, triangular, square, or oval; wherein the balloon sensor is adaptable to measure air volume, airflow, and/or temperature. 
     
     
         19 . The method of  claim 15 , wherein the cuff control system activates the deflation unit and/or the inflation unit in discreet steps or in a continuous manner to achieve/maintain the predetermined pressure; wherein the deflation unit and the inflation unit are operable and mutually independent of each other; wherein the cuff control system simultaneously activates the deflation unit and the inflation unit to maintain the predetermined pressure; wherein the cuff control system is operable as a fully automatic smart control system. 
     
     
         20 . The method of  claim 17 , wherein the inner cuff opening comprises a plurality of openings; wherein the inner cuff opening is circular, oval, square, and triangle in shape.